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Comparison of Two Dental Techniques Used to Treat Teeth Which Have Become Infected or Painful Following Trauma

Primary Purpose

Apexification, Apexogenesis, Pulp Necrosis

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Mineral trioxide aggregate
Revascularisation
Sponsored by
University of Liverpool
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apexification focused on measuring Calcium hydroxide, Pulp regeneration, Regenerative endodontics, Pulp revitalisation, Triple antibiotic paste, Root canal therapy, Root end closure, Tooth root, Tooth apex, Dental trauma, Non-vital, Immature, Incisor, Periapical periodontitis, Dental pulp

Eligibility Criteria

7 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria for participants:

  • Between 7 and 25 years of age
  • Have no significant medical history
  • Cooperative in the dental chair
  • Able to commit to the recall schedules prescribed by the study
  • Have one or more traumatised non-vital permanent maxillary central incisors with incomplete root development

Exclusion Criteria for participants:

  • Have a medical history that may complicate treatment
  • Have a medical history for which the study procedures may place the patient at increased risk
  • Have a diagnosis of avulsion or severe intrusion following dental trauma

Exclusion Criteria for Permanent maxillary central incisors:

  • Less than half formed
  • Have anatomical complexity (such as dens invaginatus)
  • Have horizontal or vertical root fractures present
  • Have evidence of root resorption

Sites / Locations

  • University of Liverpool

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Apexification with MTA

Pulp revascularisation

Arm Description

The control group will receive: Visit 1: root canal dressing with calcium hydroxide Visit 2: apexification with mineral trioxide aggregate (MTA), followed by obturation of the root canal with gutta percha. Treatment will be carried out over two visits, two weeks apart.

The experimental group will receive: Visit 1: root canal dressing with triple antibiotic paste Visit 2: pulp revascularisation procedure Treatment will be carried out over two visits, two weeks apart.

Outcomes

Primary Outcome Measures

Evidence of periapical healing
Teeth will be reviewed clinically and radiographically at 3, 6, 9 and 12 months in order to monitor healing progress. Final outcome measures will be recorded at 12 months.
Presence of a satisfactory apical barrier
Teeth will be reviewed clinically and radiographically at 3, 6, 9 and 12 months in order to monitor healing progress. Final outcome measures will be recorded at 12 months.

Secondary Outcome Measures

Patient satisfaction
Teeth will be reviewed clinically and radiographically at 3, 6, 9 and 12 months in order to monitor healing progress. Final outcome measures will be recorded at 12 months.
Evidence of root development
Teeth will be reviewed clinically and radiographically at 3, 6, 9 and 12 months in order to monitor healing progress. Final outcome measures will be recorded at 12 months.
A satisfactorily restored tooth
Teeth will be reviewed clinically and radiographically at 3, 6, 9 and 12 months in order to monitor healing progress. Final outcome measures will be recorded at 12 months.
Absence of signs and symptoms of failure of treatment (pain, mobility, tenderness to percussion, pathology e.g.sinus or swelling)
Teeth will be reviewed clinically and radiographically at 3, 6, 9 and 12 months in order to monitor healing progress. Final outcome measures will be recorded at 12 months.

Full Information

First Posted
March 18, 2013
Last Updated
December 9, 2015
Sponsor
University of Liverpool
Collaborators
Liverpool University Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01817413
Brief Title
Comparison of Two Dental Techniques Used to Treat Teeth Which Have Become Infected or Painful Following Trauma
Official Title
Revascularisation Versus Mineral Trioxide Aggregate in the Management of Non-Vital Immature Permanent Incisors in a Young Population: A Randomised Controlled Trial (Pilot Study)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liverpool
Collaborators
Liverpool University Hospitals NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Children often damage their front teeth. In approximately 6% of cases, the nerve inside the affected tooth dies (becomes 'non-vital') and natural root development stops. In these cases, the tooth requires a root canal treatment in order to prevent problems such as pain and dental abscesses from arising. However, because the roots of these young teeth are not fully formed, they are weaker and prone to fracture. In addition, root canal treatment is difficult because a root canal filling cannot be placed in a tooth which is not yet fully formed, due to the fact that the root has an 'open' end. To enable root canal treatment to be carried out, a 'barrier' must be placed at the end of the 'open' root. This can be done using materials called Calcium Hydroxide or Mineral Trioxide Aggregate (MTA). These materials are placed inside the root and sealed into the tooth. However, although they help to provide a barrier, they do not help to strengthen the walls of the root. Treatment with these materials requires multiple visits to the dentist, over a period of up to 18 months. There is evidence to suggest that an alternative treatment involving 'revascularisation' (recovery of the blood supply to the tooth) and the use of a triple antibiotic paste allows 'natural' root growth to restart, and also strengthens the walls of the root. Treatment can often be carried out in just two visits. The aim of this study is to discover whether there is a difference between one of two methods of treating non-vital teeth with open ends. It is thought that there will be no significant differences seen between the results of the two techniques. Children with teeth that fall into this category and require root canal treatment will be given one of two treatments, both of which aim to treat infection, close the root end and to allow healing to take place. Teeth will receive one of the following methods of root treatment: Revascularisation (recovery of the natural blood supply to the tooth) following placement of an antibiotic paste into the tooth root. The aim of this treatment is to allow 'natural' root growth to restart. Root growth will allow the tooth to form at barrier at the end of the root. No root canal filling will then be necessary. Closure of the open root end by placement of an artificial barrier at the end of the root so that a root canal filling can then be placed. This will be done with a dental material called Mineral Trioxide Aggregate (MTA). Non-vital teeth with an open end are routinely treated in this way at Liverpool Dental Hospital.
Detailed Description
Participants will be randomly allocated in to one of the above treatment groups. This means that neither the participants, nor the researchers, will be able to choose which group a participant will be allocated to. In both techniques, in order to learn about the bacteria involved in non-vital teeth, the investigators will take samples of the bacteria within the root canal. The outcomes of the study will provide us with further information about root growth, the bacteria involved in infection of non-vital teeth and the success of the different treatment methods that are available. This information will enable us to increase our understanding of the treatment of non-vital teeth with an open end and help us to explain our treatments to future patients. All children presenting to Liverpool University Dental Hospital aged between 7 and 25 years of age and who are medically well and cooperative to receive prolonged treatment in the dental chair are eligible to take part in the study if they have a damaged upper front adult tooth in which the nerve has died and the root is open ended. Unfortunately, if there is dental decay in the tooth or a fracture of the root then these teeth are not suitable for this study. In some cases following damage to a tooth, the root of the tooth starts to dissolve and unfortunately these teeth are also not suitable for this study. Suitable patients attend with their parent or carer for a consultation to the Paediatric Dentistry Clinic at Liverpool University Dental Hospital. Following this visit, if a suitable patient wishes to join our study the investigators will arrange two further visits during which the dental treatment will take place. Following completion of treatment, patients will be asked to return for four check ups over the next year so that the investigators can check that they are happy and that treatment has been successful. There are no risks or disadvantages to taking part in this study. However, if the tooth does not respond to treatment, or if symptoms of infection arise, then alternative treatment methods may be initiated as necessary. The study is being funded by the Royal Liverpool and Broadgreen University Hospitals NHS Trust and by the University of Liverpool.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apexification, Apexogenesis, Pulp Necrosis, MTA, Pulp Revascularisation, Periapical Periodontitis, Non-vital Immature Tooth
Keywords
Calcium hydroxide, Pulp regeneration, Regenerative endodontics, Pulp revitalisation, Triple antibiotic paste, Root canal therapy, Root end closure, Tooth root, Tooth apex, Dental trauma, Non-vital, Immature, Incisor, Periapical periodontitis, Dental pulp

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apexification with MTA
Arm Type
Active Comparator
Arm Description
The control group will receive: Visit 1: root canal dressing with calcium hydroxide Visit 2: apexification with mineral trioxide aggregate (MTA), followed by obturation of the root canal with gutta percha. Treatment will be carried out over two visits, two weeks apart.
Arm Title
Pulp revascularisation
Arm Type
Experimental
Arm Description
The experimental group will receive: Visit 1: root canal dressing with triple antibiotic paste Visit 2: pulp revascularisation procedure Treatment will be carried out over two visits, two weeks apart.
Intervention Type
Procedure
Intervention Name(s)
Mineral trioxide aggregate
Other Intervention Name(s)
MTA, MTA cement, Apexification
Intervention Description
An apical barrier of mineral trioxide aggregate (MTA cement) will be placed in the tooth root at the open apex in order to achieve root end closure via an apexification technique
Intervention Type
Procedure
Intervention Name(s)
Revascularisation
Other Intervention Name(s)
Regenerative endodontics, Pulp revitalisation, Apexogenesis
Intervention Description
Pulp revascularisation will be induced by instrumentation through the open apex so that a blood clot forms within the root canal in order to achieve root end closure via apexogenesis
Primary Outcome Measure Information:
Title
Evidence of periapical healing
Description
Teeth will be reviewed clinically and radiographically at 3, 6, 9 and 12 months in order to monitor healing progress. Final outcome measures will be recorded at 12 months.
Time Frame
12 months
Title
Presence of a satisfactory apical barrier
Description
Teeth will be reviewed clinically and radiographically at 3, 6, 9 and 12 months in order to monitor healing progress. Final outcome measures will be recorded at 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
Teeth will be reviewed clinically and radiographically at 3, 6, 9 and 12 months in order to monitor healing progress. Final outcome measures will be recorded at 12 months.
Time Frame
12 months
Title
Evidence of root development
Description
Teeth will be reviewed clinically and radiographically at 3, 6, 9 and 12 months in order to monitor healing progress. Final outcome measures will be recorded at 12 months.
Time Frame
12 months
Title
A satisfactorily restored tooth
Description
Teeth will be reviewed clinically and radiographically at 3, 6, 9 and 12 months in order to monitor healing progress. Final outcome measures will be recorded at 12 months.
Time Frame
12 months
Title
Absence of signs and symptoms of failure of treatment (pain, mobility, tenderness to percussion, pathology e.g.sinus or swelling)
Description
Teeth will be reviewed clinically and radiographically at 3, 6, 9 and 12 months in order to monitor healing progress. Final outcome measures will be recorded at 12 months.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for participants: Between 7 and 25 years of age Have no significant medical history Cooperative in the dental chair Able to commit to the recall schedules prescribed by the study Have one or more traumatised non-vital permanent maxillary central incisors with incomplete root development Exclusion Criteria for participants: Have a medical history that may complicate treatment Have a medical history for which the study procedures may place the patient at increased risk Have a diagnosis of avulsion or severe intrusion following dental trauma Exclusion Criteria for Permanent maxillary central incisors: Less than half formed Have anatomical complexity (such as dens invaginatus) Have horizontal or vertical root fractures present Have evidence of root resorption
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C C Youngson
Organizational Affiliation
University of Liverpool
Official's Role
Study Chair
Facility Information:
Facility Name
University of Liverpool
City
Liverpool
ZIP/Postal Code
L3 5PS
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.controlled-trials.com/ISRCTN34934882
Description
Current Controlled Trials Registration

Learn more about this trial

Comparison of Two Dental Techniques Used to Treat Teeth Which Have Become Infected or Painful Following Trauma

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